ICU Medical 41229-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00840619043650), received between Mar 15, 2019 and Mar 3, 2022 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (3 reports).

5 other recalls cover devices cleared under the same FDA submission (K091268); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 3, 2022Detachment of Device or Device Component; Physical Resistance/Sticking; Detachment of Device or Device Component; Physical Resistance/Sticking

  THE EVENT INVOLVING A TD CATHETER, 7F, 4 LUMEN, 110 CM, HEPARIN COATED, LF WITH MDR REPORT# MW5106528, WHERE IT WAS REPORTED THAT "DURING A CARDIAC CATHETER LAB PROCEDURE, THE STAFF WAS REMOVING A SWAN-GANZ CATHETER FROM THE PATIENT AND THEY PROCEEDED TO DEFLATE THE BALLOON BEFORE PULLING THE CATHETER FROM THE SHEATH. AFTER DEFLATING THE BALLOON, THEY BEGAN TO PULL BACK THE CATHETER. WHILE PULLING THE LAST PORTION OF THE CATHETER OUT, THERE WAS MILD RESISTANCE ENCOUNTERED BUT NOT ENOUGH TO MAKE THEM THINK THAT THE BALLOON WAS CAUGHT. AFTER FULLY REMOVING THE CATHETER FROM THE SHEATH, THEY NOTICED THAT THE TIP OF THE BALLOON DIDN'T LOOK NORMAL. THE STAFF TRIED TO REINFLATE THE BALLOON TO TEST THE INTEGRITY OF IT. WHILE TRYING TO INFLATE THE BALLOON, THEY REALIZED THE BALLOON WAS NO LONGER INTACT. A 20 CC SYRINGE WAS ATTACHED TO THE SIDE ARM OF THE SHEATH TO PULL NEGATIVE PRESSURE. THE STAFF WAS UNABLE TO PULL BACK ANY BLOOD ON THE SHEATH. THE CARDIOLOGIST WAS INFORMED, AND THE STAFF WAS INSTRUCTED TO CONTINUE PULLING NEGATIVE ON THE SYRINGE WHILE THE CARDIOLOGIST DISCONTINUED THE 7FR SHEATH. AFTER REMOVING THE 7FR SHEATH FROM THE FEMORAL VEIN, THE SHEATH WAS FLUSHED TO SEE IF THE BA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13660241 ↗
• MalfunctionMay 9, 2019Material Rupture; Material Rupture

  USER FACILITY VOLUNTARY MEDWATCH REPORT MW5085197 WAS RECEIVED THAT STATED THE FOLLOWING: ¿RIGHT HEART CATHETER INSERTED, WHEN CATHETER WAS IN PULMONARY WEDGE POSITION, USER WAS UNABLE TO PULL BLOOD FROM INNER LUMEN. CATHETER WAS REMOVED AND NOTED TO HAVE RUPTURED BALLOON TIP¿. IT WAS ADDITIONALLY INDICATED THAT THERE WAS NO ADVERSE EVENT, BUT THERE WAS A SERIOUS INJURY THAT REQUIRED INTERVENTION. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8596114 ↗
• MalfunctionMar 15, 2019Material Rupture; Material Rupture

  THE EVENT INVOLVES A TD THERMODILUTION CATHETER THAT RUPTURED WHILE THE BALLOON WAS BEING INFLATED IN THE CATH LAB. THERE WAS NO PATIENT INVOLVEMENT, NO MEDICATION INVOLVED, NO HUMAN HARM, NO ADVERSE EVENT AND NO DELAY IN CRITICAL THERAPY.

  Patient problems: No Patient Involvement

  MAUDE report 8425415 ↗
• MalfunctionMar 15, 2019Material Rupture; Material Rupture

  USER FACILITY VOLUNTARY MEDWATCH REPORT MW5084743 WAS RECEIVED THAT STATED THE FOLLOWING: "THE HEART CATHETER INSERTED, WHEN INSERTED WAS IN PULMONARY WEDGE POSITION; USER WAS UNABLE TO PULL BLOOD FROM INNER LUMEN. CATHETER WAS REMOVED AND NOTED TO HAVE A RUPTURED BALLOON TIP."¿ IT WAS ADDITIONALLY INDICATED THAT THERE WAS NO ADVERSE EVENT, BUT THERE WAS A SERIOUS INJURY THAT REQUIRED INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE AFTER REPEATED ATTEMPTS TO CLARIFY WITH THE CUSTOMER.

  Patient problems: No Information; No Patient Involvement

  MAUDE report 8425300 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K091268. One submission often covers many models, so check the product and lot details in each record.

• Z-2000-2020 · Jan 2, 2020 · Terminated
  Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring for p
• Z-2001-2020 · Jan 2, 2020 · Terminated
  Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring for p
• Z-1997-2020 · Jan 2, 2020 · Terminated
  Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring for p
• Z-1998-2020 · Jan 2, 2020 · Terminated
  Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring for p
• Z-1999-2020 · Jan 2, 2020 · Terminated
  Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring for p